MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ6 HI OFF; HIP FEMORAL STEM

Catalog Number	157012120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Cyst(s) (1800); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Anxiety (2328); Distress (2329); Depression (2361); Osteolysis (2377); Thrombosis/Thrombus (4440); Limb Fracture (4518); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.H10: e3 initial reporter occupation: lawyer.Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Pinnacle mom litigation record received.Litigation alleges severe hip pain, elevated toxic metal ions in the body, resulting to damage tissue, bones, hip joints.Ct scan demonstrated pseudotumor, bony erosions of the acetabulum and proximal femur.Plaintiff experience permanent injuries, suffering, anxiety, depression and emotional distress.Doi: (b)(6) 2008; dor: (b)(6) 2021; left hip.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The information received, will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) was not possible, because the required lot code was not provided.
Additional Manufacturer Narrative
Product complaint (b)(4).His report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
After review patient was revised based on the pathologic study results: excision of blood clot, pre-op diagnosis : infection/inflammation; metallic gray femoral stem; metallic gray acetabular cup; a metallic femoral ball.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Updated event description x-ray results showed bilateral osteoarthritis, severe on the left.Cystic changes of the acetabulum and femoral head bilaterally.Mild heterotopic ossification left hip area, presence of unspecified artificial hip joint.X-ray result showed bilateral leg weakness.(b)(6) 2010 penetration fracture at posterior cortex nondisplaced crack fracture of the calcar area.Past bilateral total hip replacement, current pain on the left side with new lump.(b)(6) 2022: impression shows: pelvic and osteolysis and chronic pain, possible infection, swelling, significant ho but implants used during revision were competitors.The patient was revised due to failed left total hip arthroplasty, open reduction and internal fixation proximal femur fracture, metallosis, osteolysis, and pseudotumor.Operative notes indicated bony destruction and evident on the proximal femur as well as a soft tissue destruction.There was significant necrotic-appearing tissue.There were significant bony erosions and the trochanter was found to be eroded posteriorly and have small fracture.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, "pinnacle mom litigation record received.Litigation alleges severe hip pain, elevated toxic metal ions in the body, resulting to damage tissue, bones, hip joints.Ct scan demonstrated pseudotumor, bony erosions of the acetabulum and proximal femur.Plaintiff experience permanent injuries, suffering, anxiety, depression and emotional distress.Doi: (b)(6) 2008; dor: (b)(6) 2021; left hip".The product was not returned to depuy synthes, however x-rays were provided for review.(b)(4).The radiological images were reviewed, however they do not represent the reported complaint condition, since the x-rays were taken two years after the reported implants were explanted.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.The overall complaint was not confirmed as the radiological images provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "pinnacle mom litigation record received.Litigation alleges severe hip pain, elevated toxic metal ions in the body, resulting to damage tissue, bones, hip joints.Ct scan demonstrated pseudotumor, bony erosions of the acetabulum and proximal femur.Plaintiff experience permanent injuries, suffering, anxiety, depression and emotional distress.Doi: (b)(6)2008; dor: (b)(6) 2021; left hip".The product was not returned to depuy synthes; however x-rays were provided for review.See attachment "(b)(4) received (b)(6) 2024, (b)(4) received (b)(6) 2024".The x-ray investigation revealed nothing indicative of a device nonconformance.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the [unknown hip femoral stem] would not contribute to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d4 (catalog, lot, expiration date), h4.Corrected: d1, d2a, d4 primary udi number.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "pinnacle mom litigation record received.Litigation alleges severe hip pain, elevated toxic metal ions in the body, resulting to damage tissue, bones, hip joints.Ct scan demonstrated pseudotumor, bony erosions of the acetabulum and proximal femur.Plaintiff experience permanent injuries, suffering, anxiety, depression and emotional distress.Doi: (b)(6) 2008; dor: (b)(6) 2021; left hip".The product was not returned to medtech orthopaedics.However, x-rays were provided for review.See attachment "(b)(4) (b)(6)2024, (b)(4) (b)(6) 2024 and (b)(4) (b)(6) 2025".The x-ray investigation revealed nothing indicative of a device nonconformance.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation was performed for the finished device [(b)(6) / be9bm1000] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the summit duofix tap sz6 hi off would not contribute to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device [(b)(6) / be9bm1000] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device [(b)(6) / be9bm1000] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: added: d10.Corrected: d4 (primary udi number).

• Brand Name: SUMMIT DUOFIX TAP SZ6 HI OFF
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16902009
• Report Number: 1818910-2023-09978
• Device Sequence Number: 20198413
• Product Code: LPH
• UDI-Device Identifier: 10603295060178
• UDI-Public: (01)10603295060178(17)170211(10)BE9BM1000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2017
• Device Catalogue Number: 157012120
• Device Lot Number: BE9BM1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 01/26/2024; 03/26/2024; 04/05/2024; 04/09/2024; 04/25/2024; 08/07/2024; 03/04/2025; 07/08/2025
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 05/11/2023; 01/29/2024; 04/05/2024; 04/09/2024; 04/16/2024; 04/26/2024; 08/08/2024; 03/13/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12/14 ARTICUL 44MM M SPEC+5.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINNACLE MTL INS NEUT44IDX62OD.; PINNACLE SECTOR II CUP 62MM.; UNK HIP ACETABULAR CUP PINNACLE.; UNK HIP ACETABULAR LINER METAL PINNACLE.; UNK HIP FEMORAL HEAD METAL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White